Status:
UNKNOWN
Stem Cell Therapy in Non-IschEmic Non-treatable Dilated CardiomyopathiEs II: a Pilot Study
Lead Sponsor:
JKastrup
Collaborating Sponsors:
University Medical Centre Ljubljana
Conditions:
Non-ischemic Dilated Cardiomyopathy
Eligibility:
All Genders
30-80 years
Phase:
PHASE1
PHASE2
Brief Summary
The overall aim of the project is to test the feasibility and safety of allogeneic adipose-derived stromal cells (CSCC\_ASC) investigational medicinal product, to improve myocardial function in patien...
Detailed Description
Study design The primary objective of the study is to investigate safety and regenerative capacity of direct intra-myocardial injection of 100 million allogeneic CSCC\_ASCs in NIDCM patients with red...
Eligibility Criteria
Inclusion
- 30 to 80 years of age
- Signed informed consent
- Patients with non-ischemic dilated cardiomyopathy
- NYHA ≥ II in spite of optimal heart failure treatment and have no other treatment options
- Heart failure medication unchanged two months prior to inclusion/signature of informed consent. Changes in diuretics accepted
- LVEF ≤ 405%
- Plasma NT-pro-BNP \> 300 pg/ml (\> 35 pmol/L)
- Patients cannot be included until three months after implantation of a cardiac resynchronisation therapy device (CRTD) and until 1 month after an ICD unit
Exclusion
- Heart Failure NYHA I
- Moderate to severe aortic stenosis (valve area \< 1.3 cm2) or valvular disease with option for surgery or interventional therapy.
- Heart failure caused by cardiac valve disease or untreated hypertension.
- If the patient is expected to be candidate for MitraClip therapy of mitral regurgitation in the 12 months follow-up period.
- Cardiomyopathy with a reversible cause that has not been treated e.g. thyroid disease, alcohol abuse, hypophosphataemia, hypocalcaemia, cocaine abuse, selenium toxicity \& chronic uncontrolled tachycardia
- Cardiomyopathy in association with a neuromuscular disorder e.g. Duchenne's progressive muscular dystrophy
- Previous cardiac surgery
- Diminished functional capacity for other reasons such as: obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) \<1 L/min, moderate to severe claudication or morbid obesity
- Clinical significant anaemia (haemoglobin \< 6 mmol/L), leukopenia (leucocytes \< 2 109/L), leucocytosis (leucocytes \> 14 109/L) or thrombocytopenia (thrombocytes \< 50 109/L)
- Reduced kidney function (eGFR \< 30 ml/min)
- Left ventricular thrombus
- Anticoagulation treatment that cannot be paused during cell injections.
- Patients with reduced immune response
- History with malignant disease within five years of inclusion or suspected malignity - except treated skin cancer other than melanoma
- Pregnant women
- Woman of childbearing potential unless βHCG negative and they should be on contraception during the trial
- Other experimental treatment within four weeks of baseline tests
- Participation in another intervention trial
- Life expectancy less than one year
Key Trial Info
Start Date :
October 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03797092
Start Date
October 1 2019
End Date
September 1 2021
Last Update
January 19 2021
Active Locations (1)
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1
The Heart Centre, Rigshospitalet University Hospital Copenhagen,
Copenhagen, Denmark, 2100